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DP13 - A Phase II Study in Patients With Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT04007406
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Damian Pharma AG

Brief Summary:
The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Drug: DP13 Phase 2

Detailed Description:
A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in 36 patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : September 7, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DP13 low
DP13 for 8 weeks
Drug: DP13
DP13 systemic administration

Experimental: DP13 middle
DP13 for 8 weeks
Drug: DP13
DP13 systemic administration

Experimental: DP13 high
DP13 for 8 weeks
Drug: DP13
DP13 systemic administration




Primary Outcome Measures :
  1. Change in aldosterone [ Time Frame: 8 weeks ]
    Change in aldosterone from baseline

  2. Change in ambulatory blood pressure [ Time Frame: 8 weeks ]
    Change in ambulatory blood pressure from baseline


Secondary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: 12 weeks ]
    Occurrence of treatment-emergent adverse events and serious adverse events over entire study duration

  2. Change in blood pressure [ Time Frame: 12 weeks ]
    Change in blood pressure from baseline


Other Outcome Measures:
  1. Change in potassium from baseline [ Time Frame: 12 weeks ]
    Change in electrolytes

  2. Change in sodium from baseline [ Time Frame: 12 weeks ]
    Change in electrolytes

  3. Steady state pharmacokinetics [ Time Frame: 8 weeks ]
    Change in DP13 concentrations



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with a guideline-recommended diagnosis of primary aldosteronism

Exclusion Criteria:

Patients with primary aldosteronism and

  • hyperkalemia
  • prolonged QT intervals
  • refusal of special contraception measures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007406


Contacts
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Contact: Paolo Mulatero, Prof 0116336920 paolo.mulatero@unito.it
Contact: Hans-Rudolf Brunner, Prof. 0616412510 hrbrunner13@gmail.com

Locations
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Italy
Ospedale Molinette Recruiting
Torino, Italy, 10126
Contact: Paolo Mulatero, Prof.    0116336920    paolo.mulatero@unito.it   
Sponsors and Collaborators
Damian Pharma AG
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Responsible Party: Damian Pharma AG
ClinicalTrials.gov Identifier: NCT04007406    
Other Study ID Numbers: DP13C201
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases